Coordinated activities for the development of new and abbreviated drug applications, ensuring compliance with established safety, efficacy and quality requirements.As team leader, provided technical support in technology transfer projects, identifying and mitigating risks inherent to product/process.Provided technical assistance to senior management supporting strategic business decision-making, actively contributing to the sustainable growth of the organization.

Provided technical support to the pharmaceutical technology team for the development of formulations and manufacturing processes.Acted as backup of the direct manager in matters related to product development, technology transfer and troubleshooting.

Development of formulations and manufacturing processes for new and abbreviated drug application.Definition of rationale and strategies for product development under Quality by Design approach.Definition of critical quality attributes of products, intermediates and material. Definition of critical process parameters and process control strategy.Planning and performing experiments using DoE statistical toolsParticipation in risk management processes to build product quality through product and process understanding.Scaling up processes from laboratory scale to pilot/ industrial scales.Supporting the manufacturing of clinical trial and validation batches in GMP environment.

Development of formulations and manufacturing processes for new and abbreviated drug products.Planning and/ or executing several studies for product development, such as: raw material characterization studies, forced degradation studies, compatibility, stability and photostability.Preparation of protocols, reports and dossiers to document development activities and/or for regulatory purposes.

Validation of manufacturing processes from bacterial and viral antigens and vaccines, biopharmaceuticals and diagnostic kits.Staff training for correct dress and conduct in clean rooms.Recovery, collection and analysis of samples for residue quantification in cleaning validations.Planning, monitoring and evaluating aseptic filling processes using culture media (media fill).Microbiological sampling of surfaces and air for classification of controlled environments.Handling, seeding, growing and isolating of microorganisms for research and quantification of contaminants from microbiological origin.Preparation of protocols and process validation reports.